[Federal Register Volume 87, Number 233 (Tuesday, December 6, 2022)]
[Notices]
[Pages 74632-74634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26501]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3431-N2]


Medicare Program; Virtual Meeting of the Medicare Evidence 
Development and Coverage Advisory Committee; Cancellation of the 
December 7, 2022 Virtual Meeting and Announcement of the February 13 
and February 14, 2023 Virtual Meetings

AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and 
Human Services (HHS).

ACTION: Notice.

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SUMMARY: This notice announces the cancellation of the December 7, 2022 
virtual public meeting of the Medicare Evidence Development & Coverage 
Advisory Committee (MEDCAC) (``Committee'') that was published in the 
October 11, 2022 Federal Register. This notice also announces a virtual 
public meeting of the MEDCAC Committee on Monday, February 13 and

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Tuesday, February 14, 2023. National Coverage Determinations resulting 
in coverage with evidence development (CED) can expedite earlier 
Medicare beneficiary access to innovative technology while ensuring 
that systematic patient safeguards are in place to reduce the risks 
inherent to new technologies, or to new applications of older 
technologies. This meeting will examine the general requirements for 
clinical studies submitted for CMS coverage requiring CED. The MEDCAC 
will evaluate the CED criteria to assure that CED studies are evaluated 
with consistent, feasible, transparent and methodologically rigorous 
criteria and advise CMS on whether the criteria are appropriate to 
ensure that CED-approved studies will produce reliable evidence that 
CMS can rely on to help determine whether a particular item or service 
is reasonable and necessary. This meeting is open to the public in 
accordance with the Federal Advisory Committee Act.

DATES: 
    Meeting Date: The virtual meeting will be held on Monday, February 
13 and Tuesday, February 14, 2023 from 10:00 a.m. until 3:00 p.m., 
Eastern Standard Time (EST).
    Deadline for Submission of Written Comments: Written comments must 
be received at the email address specified in the ADDRESSES section of 
this notice by 5:00 p.m., Eastern Standard Time (EST), on Friday, 
January 13, 2023. Once submitted, all comments are final.
    Deadlines for Speaker Registration and Presentation Materials: The 
deadline to register to be a speaker and to submit PowerPoint 
presentation materials and writings that will be used in support of an 
oral presentation is 5:00 p.m., EST, on Friday, January 13, 2023. 
Speakers may register by phone or via email by contacting the person 
listed in the FOR FURTHER INFORMATION CONTACT section of this notice. 
Presentation materials must be received at the email address specified 
in the ADDRESSES section of this notice.
    Submission of Presentations and Comments: Presentation materials 
and written comments that will be presented at the meeting must be 
submitted via email to [email protected] section of this 
notice by Friday, January 13, 2023.
    Deadline for All Other Attendees Registration: Individuals who want 
to join the meeting may register online at https://cms.zoomgov.com/webinar/register/WN_CsJL7k7kQcyY0Z20OR6eqw by 11:59 p.m. EST, on 
Sunday, February 12, 2023.
    Webinar and Teleconference Meeting Information: Teleconference 
dial-in instructions, and related webinar details will be posted on the 
meeting agenda, which will be available on the CMS website http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. Participants in the MEDCAC meeting will 
require the following: A computer, laptop or smartphone where the Zoom 
application needs to be downloaded; a strong Wi-Fi or an internet 
connection and access to use Chrome or Firefox web browser and a webcam 
if the meeting participant is scheduled to speak or make a presentation 
during the meeting.
    Deadline for Submitting a Request for Special Accommodations: 
Individuals viewing or listening to the meeting who are hearing or 
visually impaired and have special requirements, or a condition that 
requires special assistance, should send an email to the MEDCAC 
Coordinator as specified in the FOR FURTHER INFORMATION CONTACT section 
of this notice no later than 5:00 p.m., EST on Monday, January 23, 
2023.

ADDRESSES: Due to the current COVID-19 public health emergency, the 
Panel meeting will be held virtually and will not occur at the campus 
of the Centers for Medicare & Medicaid Services (CMS), Central 
Building, 7500 Security Boulevard, Baltimore, Maryland 21244.

FOR FURTHER INFORMATION CONTACT: Tara Hall, MEDCAC Coordinator, via 
email at [email protected] or by phone 410-786-4347.

SUPPLEMENTARY INFORMATION: 

I. Background

    MEDCAC, formerly known as the Medicare Coverage Advisory Committee 
(MCAC), is advisory in nature, with all final coverage decisions 
resting with CMS. MEDCAC is used to supplement CMS' internal expertise. 
Accordingly, the advice rendered by the MEDCAC is most useful when it 
results from a process of full scientific inquiry and thoughtful 
discussion, in an open forum, with careful framing of recommendations 
and clear identification of the basis of those recommendations. MEDCAC 
members are valued for their background, education, and expertise in a 
wide variety of scientific, clinical, and other related fields. (For 
more information on MEDCAC, see the MEDCAC Charter (http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/Downloads/medcaccharter.pdf) and 
the CMS Guidance Document, Factors CMS Considers in Referring Topics to 
the MEDCAC (http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=10).

II. Meeting Topic and Format

    This notice announces the February 13 and February 14, 2023, 
virtual public meeting of the Committee. This meeting will examine the 
requirements for clinical studies submitted for CMS coverage under 
coverage with evidence development (CED). It has been 8 years since the 
criteria for CED were last evaluated and revised. In that time, not 
only have technologies become more complex, but there has been growing 
appreciation and commitment to transparency in decision-making, to 
making certain that study methodologies are ``fit to purpose'' as 
determined by the topic, questions asked, health outcomes studied, and 
to making certain that the populations studied are representative of 
the diversity in the Medicare beneficiary population. For example, some 
questions may be sufficiently answered through analysis of real-world 
evidence including data from clinical registries, electronic health 
records, and administrative claims. Any decision about whether an item 
or service is reasonable and necessary must, minimally, be sensitive to 
these commitments as well as to ensuring that study participants' 
interests are respected and protected. The MEDCAC will evaluate the CED 
criteria to assure that CED studies are evaluated with consistent, 
feasible, transparent and methodologically rigorous criteria and advise 
on whether the criteria are appropriate to ensure that CED-approved 
studies will produce reliable evidence that CMS can rely on to help 
determine whether a particular item or service is reasonable and 
necessary.
    Background information about this topic, including panel materials, 
is available at http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. Electronic copies of all 
the meeting materials will be on the CMS website no later than 2 
business days before the meeting. We encourage the participation of 
organizations, researchers and people with expertise or interest in the 
thoughtful, efficient design and implementation of clinical studies 
whose goals are to improve the health of people, especially Medicare 
beneficiaries. This meeting is open to the public. The Committee will 
hear oral presentations from the public. Time allotted for each 
presentation may be limited. If the number of registrants requesting to 
speak is greater than what can be reasonably accommodated

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during the scheduled open public hearing session, we may conduct a 
lottery to determine the speakers for the scheduled open public hearing 
session. The contact person will notify interested persons regarding 
their request to speak no later than 1 week from the speaker 
registration deadline specified in the DATES section of this notice. 
Your comments must focus on issues specific to the list of topics that 
we have proposed to the Committee. The list of research topics to be 
discussed at the meeting will be available on the following website 
prior to the meeting http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. We require that 
you declare at the meeting whether you have any financial involvement 
with manufacturers (or their competitors) of any items or services 
being discussed. Speakers presenting at the MEDCAC meeting must include 
a full disclosure slide as their second slide in their presentation for 
financial interests (for example, type of financial association--
consultant, research support, advisory board, and an indication of 
level, such as minor association <$10,000 or major association> 
$10,000) as well as intellectual conflicts of interest (for example, 
involvement in a federal or nonfederal advisory committee that has 
discussed the issue) that may pertain in any way to the subject of this 
meeting. If you are representing an organization, we require that you 
also disclose conflict of interest information for that organization. 
If you do not have a PowerPoint presentation, you will need to present 
the full disclosure information requested previously at the beginning 
of your statement to the Committee.
    The Committee will deliberate openly on the topics under 
consideration. Interested persons may observe the deliberations, but 
the Committee will not hear further comments during this time except at 
the request of the chairperson. The Committee will also allow a 15-
minute unscheduled open public session for any attendee to address 
issues specific to the topics under consideration. By the conclusion of 
the second day, the panel members will vote and the Committee will make 
its recommendation(s) to CMS.

III. Registration Instructions

    CMS' Coverage and Analysis Group is coordinating meeting 
registration. While there is no registration fee, individuals must 
register to attend. You may register online at https://cms.zoomgov.com/webinar/register/WN_CsJL7k7kQcyY0Z20OR6eqw or by phone by contacting 
the person listed in the FOR FURTHER INFORMATION CONTACT section of 
this notice by the deadline listed in the DATES section of this notice. 
Please provide your full name (as it appears on your state-issued 
driver's license), address, organization, telephone number(s), and 
email address. You will receive a registration confirmation with 
instructions for your participation at the virtual public meeting.

IV. Collection of Information

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. chapter 35).
    The Chief Medical Officer and Director of the Center for Clinical 
Standards and Quality for the Centers for Medicare & Medicaid Services 
(CMS), Lee A. Fleisher, having reviewed and approved this document, 
authorizes Lynette Wilson, who is the Federal Register Liaison, to 
electronically sign this document for purposes of publication in the 
Federal Register.

    Dated: December 1, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-26501 Filed 12-5-22; 8:45 am]
BILLING CODE 4120-01-P